QUALITY CHOICE SINGLE SALINE  LAXATIVE- sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema 
Alcyon Health, LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

QUALITY CHOICE SINGLE SALINE ENEMA
LAXATIVE

Drug Facts

Active ingredients (in each 118 mL delivered dose)Purpose
Dibasic Sodium Phosphate 7 gSaline laxative
Monobasic Sodium Phosphate 19 gSaline laxative

Use

Relieves occasional constipation

Warnings

For rectal use only

Dosage warning

Using more than one enema in 24 hours can be harmful.

Ask a doctor before use if you

  • already used a laxative for more than 1 week
  • are dehydrated
  • have kidney disease
  • are 55 years old or older
  • have heart problems
  • are on a sodium-restricted diet

Ask a doctor before using any laxative if you have

  • abdominal pain, nausea, or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week

When using this product

  • do not use more than directed. Serious side effects may occur from excess dosage.
  • do not use for more than 3 days

Stop use and ask a doctor if

  • you have bleeding
  • the condition worsens or does not improve within 7 days
  • you have no bowel movement within 30 minutes of enema use
  • you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)

These symptoms may indicate a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Single daily dosage (per 24 hours)

Do not use if taking another sodium phosphate product.

Do not use more unless directed by a doctor. See Warnings.

Adults and Children 12 years old and older1 bottle once daily
Children 2 to under 12 years old1/2 bottle once daily
Children under 2 yearsDO NOT USE

Other information

Inactive ingredients

Benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

1-844-624-2633 or www.maiamed.com

Distributed By:
Maia Medical
655 Metro Place South, Suite 600-050
Dublin, OH 43017 USA

PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton

maia
medical™

SALINE
enema

6 Bottles
4.5 Fl Oz (133 ml) each

Latex Free

PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton
QUALITY CHOICE SINGLE SALINE   LAXATIVE
sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71443-001
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM19 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71443-001-066 in 1 CARTON07/05/2017
1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/05/2017
Labeler - Alcyon Health, LLC. (080040408)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(71443-001)

Revised: 7/2017
Document Id: 987aa9cc-4f7e-442b-b901-a60597a5ad32
Set id: eb499c7f-9c7b-4097-83a3-82aabffd6beb
Version: 1
Effective Time: 20170712
 
Alcyon Health, LLC.